NCT06410313招募中不适用
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Medinol Ltd.
- 入组人数
- 30
- 试验地点
- 11
- 主要终点
- Primary patency of the target lesion
研究概览
简要总结
This is a prospective, open label, multicenter, single arm, first in human clinical study.
Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and of age of legal consent.
- •Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.
- •A single superficial femoral artery lesion with >50% stenosis or total occlusion.
- •Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
- •Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
- •Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
- •Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
- •The target lesion(s) can be successfully crossed with a guide wire and dilated.
- •The subject is eligible for standard surgical repair, if necessary.
- •Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.
排除标准
- •Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
- •Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- •Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
- •Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
- •Presence of an ipsilateral arterial artificial graft.
- •Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
- •Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- •Required stent placement (in the target or any other lesion) via a retrograde approach.
- •Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
- •Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
- •Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
- •Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
- •Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
- •Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
- •Subject has tissue loss, defined as Rutherford-Becker classification category 5 or
- •Overlapping stents are not allowed.
- •Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
- •Stroke within the previous 30 days of the index procedure.
- •Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), PDLG, PLC, PDL, limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds) or contrast agent, that cannot be medically managed.
- •Receiving dialysis or immunosuppressant therapy within the previous 30 days.
- •Known or suspected active systemic infection at the time of the procedure.
- •Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
- •Platelet count <50,000/μL
- •International normalized ratio (INR) > 1.5
- •GFR <30 ml/min by Cockroft-Gault.
- •Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
- •Planned use of a drug coated balloon (DCB) during the index procedure.
- •Pregnant women or women of childbearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment.
- •Subject is participating in any investigational study that has not yet reached its primary endpoint
结局指标
主要结局
Primary patency of the target lesion
时间窗: 6 months
Primary patency of the target lesion defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) ≥2.4).
Primary safety endpoint
时间窗: 30 days
Composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation
次要结局
- Change of resting ankle-brachial index (ABI)(30 days 6, 12, 24 and 36 months)
- Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization(30 days)
- Acute device success(During the index procedure)
- All-cause death(30 days, 6, 12, 24 and 36 months)
- Secondary Patency(30 days 6, 12, 24 and 36 months)
- Acute procedural success(During the index procedure)
- Change of Rutherford classification(30 days 6, 12, 24 and 36 months)
- Stent fracture(12 and 36 months)
- Target Lesion Revascularization (TLR)(30 days, 6, 12, 24 and 36 months)
- Primary patency(30 days and 12 months)
- Acute technical success(During the index procedure)
- Combined rate of the following events: death at 30 days, target vessel revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)(12 months)
- Target Vessel Revascularization (TVR)(30 days, 6, 12, 24 and 36 months)
- Rate of Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature(30 days, 6, 12, 24 and 36 months)
- Change in walking impairment questionnaire(30 days 6, 12, 24 and 36 months)
- Amputation (above the ankle)-Free Survival (AFS)(30 days, 6, 12, 24 and 36 months)
- Major Adverse Limb Events (MALE)(30 days, 6, 12, 24 and 36 months)
研究者
研究点 (11)
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